Sammy Lee: Human error is no excuse as IVF clinics fail to learn from mistakes

Published on Monday 6 July 2009 20:49

IN 2002, the UK IVF world was shattered by the media revelation of a fertilisation blunder in Leeds that saw a white couple have black twins.

At the time, even though most clinics had a form of double-checking system, there was no "common rule" from the governmental regulator – the Human Fertilisation and Embryology Authority (HFEA) – and each clinic was responsible for its own protocols.

Following the 2002 incident, clinics in the UK and the HFEA put in place a number of changes that were meant to reduce, if not completely prevent, any future risk of such events. At the time, the "human error" mantra was used a great deal.

A key change was the introduction of double witnessing. In theory, every lab procedure must be checked and verified by a second person, ideally a scientist or medical doctor. Additional measures included implementation of quality systems to ensure that there would be a clear paper trail for all movement of eggs, sperm and embryos. These measures were recommended in the Toft Report.

In 2003, the professional body of embryologists and the HFEA announced a new alert system, which they claimed would help to reduce the likelihood of errors while providing full and faster information to all clinics whenever errors took place. They hoped to restore public confidence in IVF clinics, which were said to be potentially understaffed and overworked. However, the first six months of 2009 has seen an embryo mix-up at Guy's and St Thomas' Hospital in London and another at the IVF Wales clinic in Cardiff.

Once again, the mantra "to err is human" has been trotted out and most experts say everything that needs to be done has been. Experts also tout the idea of electronic tagging, which the HFEA has been considering since 2005 and only a handful of units use.

The most worrying matter arising from these recent events is not that they happened – to err is human – but to err and err is a concern. Apparently both units were warned at previous inspections about working practices. Perhaps both heeded the warnings and were simply unlucky.

Interestingly, both hospitals issued statements saying any shortcomings had now been addressed and, in future, such mistakes were now unlikely – shutting the barn door after the horse has bolted?

The alert system is a good idea, yet if inspections revealed poor practice that actually represents poor compliance, general alerts to other clinics should have taken place to remind everyone to scrutinise their own systems and maintain vigilance.

Moreover, even with direct warnings from the HFEA to both clinics, mistakes still followed, therefore, the alert system may not be working in the way it had hoped.

Did the HFEA follow up the warnings and was it happy that methods had been tightened? If the alert system is not working, is it weak because of complacency?

In 2006, the HFEA announced: "We want to tighten security so that errors aren't made by clinics." Electronic tagging, barcodes, colour coding, double witnessing, etc, have all been considered. Barcoding and electronic tagging have, at various times, been heralded as solutions, but have not been implemented across the board because of cost and the fact they are not fail safe. In fact, the jewel in the crown of the Toft Report was the paper trail and the requirement for proper risk management. Risk assessment needs to become second nature, but it is onerous and generates plenty of paperwork. The pharmaceutical industry is expert at this, using quality assurance in Good Manufacturing Practice (GMP), the "Bible" for quality management.

Good quality assurance demands good quality management from within, with regular internal and external audits The quality needs to be regularly stress tested and, ideally, patient cases should be audited routinely from egg collection to embryo transfer.

The paper trail and adherence to stated methodologies need to be scrutinised and validated. Only if everything checks out over several test cases can the lab be considered compliant. Compliance means demonstrating to an independent auditor that protocols are being followed exactly.

IVF practitioners consider themselves first-class professionals working at a very high level of performance, which is generally justified. However, it is not until they encounter pharmaceutical production or a GMP compliant stem cell facility that they might realise that they are but, in truth, "enthusiastic amateurs".

To be GMP compliant is to come closer to perfection than otherwise possible. And yet, you know you are dealing with a true quality professional, when in spite of being GMP compliant, they state: "What can go wrong will go wrong". Murphy's Law acknowledges, even in the sight of perfection, systems fail.

What is needed is eternal vigilance, but even then we acknowledge that we can and will fail. The quality professional is always wary of the individual who says "it will never happen again".

Perhaps this is what needs to be stressed to staff in IVF clinics – that "quality" is a professional competence to be taken seriously and reinforced by certification, not simply in-house training. The HFEA requires clinics to appoint quality managers, which is a very good idea. In the pharmaceutical industry, these managers must have appropriate training and experience.

It would be interesting to see who is fulfilling this role in the units, what training they received and what previous experience they have. Furthermore, everyone working in laboratories needs formal training in GLP/GMP and this should be properly certified and audited. Human error is likely to be occurring because, even though good systems are in play, insufficient attention to detail and failure to audit staff may be allowing laxness to creep in.

Everyone must consider themselves responsible for patients' treatment safety and success. All staff should verify the patients' and their materials' identity and validity whenever and wherever possible. Much has been done. Perhaps where more needs to be done is in implementation. Only the inspection teams and the clinics themselves know the true answer to this.

Reflection on professional practice reminds us all that, even when we have more than 20 years' experience and are considered experts, we never stop learning and we can always do better.

After reflection, any clinic that even remotely suspects that it is not as professional in carrying out its quality assurance as it might be, needs to take action.

The pharmaceutical and medical devices industry has been going for a long time – they are the "professionals"; there are plenty of well- experienced well-qualified quality assurance consultants (GLP/GMP compliance auditors) out there. Have these experts been brought in to train the quality managers in IVF clinics? Have they been employed to set up routine compliance audits? If not why not?

There is no need to reinvent the wheel, the Medicines and Healthcare products Regulatory Agency has the resources, has it been asked to second personnel?

The more the quality assurance complies with GMP-like standards, the less likely errors will be and the more patients will trust the clinics.

&#149 Sammy Lee is a clinical scientist in human embryology who teaches ethics in reproduction at University College London